Duns Number:017524666
Device Description: Premium UNIFY RPGA Surgical Sutures, Absorbable, 5-0, 13mm 3/8 Circle Rev Cut, 18". Undye Premium UNIFY RPGA Surgical Sutures, Absorbable, 5-0, 13mm 3/8 Circle Rev Cut, 18". Undyed
Catalog Number
-
Brand Name
Premium UNIFY RPGA Surgical Sutures
Version/Model Number
PSK-518R13
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
-
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
Yes
Prescription Use (Rx)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K183004,K183004,K183004
Product Code
GAM
Product Code Name
Suture, Absorbable, Synthetic, Polyglycolic Acid
Public Device Record Key
929843ea-45cf-413e-9920-8dd03bf62ae9
Public Version Date
February 05, 2021
Public Version Number
2
DI Record Publish Date
August 04, 2020
Package DI Number
10814639024439
Quantity per Package
12
Contains DI Package
00814639024432
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Box
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 73 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 121 |